The Food and Drug Administration plans to require the manufacturers of automated external defibrillators to submit pre-market approval applications for those devices as part of a broader effort to reclassify how some high-risk devices are regulated.
The agency said in a statement that the proposed order is expected to improve the quality and reliability of AEDs.
There have been at least 45,000 malfunctions and adverse events and 88 recalls of AEDs during a seven-year period beginning in 2005.
AEDs are classified as class III devices, which are considered the most high-risk devices on the market, but have traditionally been cleared through the FDA's expedited 510(k) process, which is less stringent and does not require clinical testing to gain marketing clearance.
“Automated external defibrillators save lives,” Dr. William Maisel, deputy director of science and chief scientist at the FDA's Center for Devices and Radiological Health
, said in a news release. “However, the agency is concerned about the number of recalls and manufacturing problems that have been associated with these devices, and we're committed to working with manufacturers to address these issues.”
The agency is in the process of evaluating 26 high-risk devices that have been cleared as follow-on products, rather than going through the more rigorous PMA process.
The FDA in January proposed that the manufacturers of metal-on-metal hip implants
, which have reported higher failure rates, should submit premarket approval applications for those devices. The metal implants have traditionally been cleared under the FDA's 510(K) premarket notification pathway.
During a call with reporters, Maisel said it will not be necessary to remove AEDs from the market during the transition period. The final order would be expected to go into effect by the end of 2014.
There are seven manufacturers of AEDs in the U.S.
A spokesman for Philips Healthcare, which manufactures AEDs, said in a statement that the company recognizes the need for “appropriate regulation for external defibrillators” and remained “committed to working with the FDA to ensure the best application of technology and clinical experience in support of AED performance and reliability.”
The comment period is 90 days.